This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).
Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Male or female aged ≥18 years and ≤70 years.
Histologically or cytologically documented SCLC.
Has received prior therapy with only one prior platinum-based line as systemic therapy for ES SCLC and Disease progression on or after first-line platinum-based regimens (≤ 6 months).
Hypersensitivity to any ingredient of JK-1201I and Topotecan.
Has received prior treatment with DNA topoisomerase I inhibitor agents.
Has received prior therapy with ≥2 line as systemic therapy for extensive-stage SCLC.
Chemotherapy-free interval within 4 weeks before the first use of the study drug. Radiotherapy with a limited field of radiation for palliation within 2 weeks before the first use of the study drug. Used biotherapy drugs within 2 weeks before the first use of the study drug.